ALBUMIN GEN.2

Additional Manufacturer Narrative

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Description of Event or Problem

THE CUSTOMER COMPLAINED OF ISSUES WITH A NEW LOT OF ALBUMIN GEN.2 (ALB2) REAGENT THAT DOESN'T SEEM TO BE MAINTAINING CALIBRATION. THE NEW ALB2 REAGENT LOT NUMBER IS 119319 EXPIRING 02/28/2017 RECEIVED ON 01/11/2016. THE OLD LOT NUMBER WAS 619340 AND THE CUSTOMER IS NOT HAVING ANY ISSUES WITH THAT LOT. THE NEW REAGENT LOT WAS LOADED ONTO THE INSTRUMENT ON (B)(6) 2016 AND THE CUSTOMER RECEIVED CALIBRATION ERRORS. QUALITY CONTROLS (QC) WERE IN RANGE. AS THE REAGENT PACK WAS USED UP, THE QC VALUES DROPPED OUT OF RANGE. THE CUSTOMER REPEATED 35 PATIENT SAMPLES TESTED FOR ALB2. DATA WAS PROVIDED FOR 30 PATIENT SAMPLES. OF THE DATA PROVIDED, 7 PATIENT SAMPLES WERE ERRONEOUS AND REPORTED OUTSIDE OF THE LABORATORY. CORRECTED REPORTS WERE ISSUED AFTER REPEAT TESTING WAS PERFORMED. (B)(6). NO ADVERSE EVENT OCCURRED. THE C 702 ANALYZER SERIAL NUMBER (B)(4). A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. IT WAS NOTED THAT THE REAGENT PACKS MAY HAVE FROZEN DURING DELIVERY ON (B)(6) 2016 AS THE SAME REAGENT PACK LOT DELIVERED ON (B)(6) 2016 WAS NOT AFFECTED AND IS HOLDING THEIR CALIBRATION. THE INSTRUMENT WAS CHECKED AND CALIBRATION AND QUALITY CONTROLS WERE ACCEPTABLE.

Additional Manufacturer Narrative

THE CUSTOMER NO LONGER HAS THE SPECIFIC REAGENT PACKS TO RETURN FOR INVESTIGATION. THE ROOT CAUSE OF THE ISSUE IS ASSUMED TO BE THE DETERIORATION OF THE INDIVIDUAL REAGENT PACKS THAT THE CUSTOMER COMPLAINED ABOUT. FACTORS SUCH AS STORAGE OR SHIPMENT CONDITIONS CAN INFLUENCE THE QUALITY OF THE PRODUCT RECEIVED. THE CUSTOMER IS STILL USING THE SAME ALB2 LOT NUMBER. THE CUSTOMER HAS NOT HAD ANY ADDITIONAL CALIBRATION OR QUALITY CONTROL ISSUES WITH THE LOT NUMBER IN USE. ALB2 TESTS ARE BEING RUN WITH NO PROBLEMS. NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS LOT.